In the article our team investigated the use of an alternative purification method for BsAbs – a commercially available CaptureSelect CH1-XL affinity resin.
Trusted CMC Advisors
Experts in biologics manufacturing, quality assurance, regulatory compliance and project management
Helping you navigate the complex demands of product development
Your Alira Health team has in-depth understanding of the technical and regulatory challenges of drug development. Led by Steven Chamow, PhD, an industry leading expert with over 30 years of experience, our team of subject matter experts will work closely with you to guide you through the most demanding projects.
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Why choose Alira Health to support your CMC needs?
For over a decade, our dedicated CMC solutions team has supported our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
Partnering for Successful CMC Solutions
Whether you need to understand which asset best aligns with your long-term strategy, which new market or therapeutic area to explore, or how to expand into another sector, we are ready to help you lead the way.
Integrity, competence, and collaboration are the foundation of our partnerships. This has allowed us—for over a decade—to help clients succeed in bringing new medicines to market.
Meet the Team
Steven Chamow, Ph.D.Senior Vice President, CMC Development
Steven Chamow is an experienced biotechnology executive and consultant, with more than 35 years of biopharmaceutical experience. As principal consultant, Dr. Chamow draws on his extensive technical and product development background to assist biotechnology companies in designing and developing CMC strategies for products in development, including transfer to and implementation by qualified CDMOs.
Prior to founding Chamow & Associates, Dr. Chamow served as senior vice president, CMC at Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics). Prior to Intradigm, Dr. Chamow was vice president, process sciences, at Genitope Corporation and at Abgenix, Inc. (acquired by Amgen), where he built the company’s process sciences department and co-led the design and construction of Abgenix’s award-winning mammalian-cell production facility in Fremont, CA. | Learn More
Sean Forestell, Ph.D. Director CMC Operations
Sean Forestell, Ph.D. is an expert in biologics process development and manufacturing with over 30 years of experience in the biotech industry. Dr. Forestell has had senior leadership roles in several companies including BioMarin, Genentech and Novartis. At BioMarin, he was the Senior Director of MSAT responsible for technical process support of 5 commercial and 4 clinical products across 4 manufacturing facilities. He has developed processes and been involved in the successful tech transfer of 12 early-stage clinical products, 4 successful PPQs that led to licensure, and has supported the manufacture of 8 different commercial products.
His broad experience includes products that range from viral vectors used in cell and gene therapy, monoclonal antibodies, and enzymes to treat ultra rare diseases that are produced using continuous manufacturing technologies. Dr. Forestell was educated at the University of Guelph, earning a BSc in Biological Engineering and a Ph.D. in Chemical Engineering from the University of Calgary. He has co-authored 19 articles in peer-reviewed journals and is an inventor on two issued patents. | Learn More
Peter Alexander, Ph.D. Senior Consultant, CMC
Upstream Process Development/ DS Manufacturing
Peter Alexander, Ph.D., is a Senior Consultant for CMC at Alira Health. Peter has more than 35 years of experience in the biopharmaceutical industry. Peter supports clients by overseeing DS operations at CDMOs, including reviewing protocols, reports and manufacturing batch records. His specialties include microbial fermentation and mammalian cell culture process development and scale-up, purification process development, technology transfer, manufacturing sciences, cGMP manufacturing and biological and chemical safety programs. Peter holds a PhD in Microbiology from the University of Hawaii. | Learn More
Bill Perry, Ph.D. Senior Consultant, CMC
Downstream Process Development/Conjugation/ DS Manufacturing
Bill Perry, Ph.D., is a Senior Consultant for CMC at Alira Health. Bill is a bioprocess engineering technical leader with 17 years of experience in industry. Bill supports clients by overseeing DS operations at CDMOs, including reviewing protocols, reports and manufacturing batch records. His experience includes products at various stages of development, from pre-clinical/clinical development and manufacturing, through process validation and commercialization. He has expertise in biologic products from mammalian cell culture and microbial fermentation. Moreover, he has skills in synthetic oligonucleotide and protein-payload conjugated products. He holds a PhD in Chemical Engineering from the Massachusetts Institute of Technology. | Learn More
Susan BabukaConsultant, CMC
Formulation Development / DP Manufacturing
Susan Babuka is a Consultant for CMC at Alira Health. Susan has over 20 years of experience, Susan Babuka is a results-driven formulation scientist specializing in formulation development, analytical method optimization, and process troubleshooting. Susan’s support for clients includes overseeing DP operations at CDMOs, including reviewing protocols, reports and manufacturing batch records. Her track record boasts scientific expertise, project leadership, and creative problem-solving. Notably, at Agenus Bio, Berkeley, CA, she led the setup of two cutting-edge formulation labs, conducted Phase I development for two monoclonal antibody candidates, and oversaw Phase II/III projects. Susan's contributions extend to crafting critical BLA and IND sections, supervising lab associates, and designing admixture studies for clinical administration. Susan was educated at State University of New York at Binghamton, earning a BS and MA in Biology. | Learn More
Katie Black, Ph.D.Consultant, CMC
Analytical Method Development and QC
Katie Black, Ph.D., is a Consultant for CMC at Alira Health. Katie Black is an experienced leader with 10 years industry experience and a multidisciplinary background spanning preclinical research through analytical development/CMC and clinical assay support. Katie’s support for clients includes overseeing the development, transfer, implementation and qualification of analytical methods at contract laboratories and CDMOs, including reviewing protocols, reports and SOPs and interpreting analytical data. Her tenure at BioMarin Pharmaceutical showcased her diverse skills in biomarker and product characterization assay development for protein therapeutics. Katie holds a BS in Chemical Engineering from Northeastern University, and a PhD in Bioengineering from UC Berkeley, with earlier industry experience at Albany International, Genzyme, and Draper Labs. | Learn More
Nick Gaspar, Ph.D.Senior Consultant, CMC
Bioanalytical Method Development and QC
Nick Gaspar, Ph.D., is a Senior Consultant for CMC at Alira Health. With over 26 years of experience in leadership roles in six biotech companies, Nick has expertise in antibodies, peptides, growth factors and oncolytic viruses (OV’s) and a background that spans drug development phases from discovery research, through clinical validation, and manufacturing. Nick’s support for clients includes overseeing the development, transfer, implementation and qualification of bioanalytical methods (specifically potency methods) at contract laboratories and CDMOs, including reviewing protocols, reports, SOPs and trending and interpreting analytical data. He received a BS (Zoology) and PhD (Molecular Biology and Biochemistry) from UC Davis. He has published 7 papers and is a co-inventor on 2 patents.
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Our experts conducted a deep evaluation of IgG-like bsAbs including general advantages and disadvantages compared with MAbs and more.
In this webinar, you’ll learn how to identify key solution features, define patient experience expectations, generate evidence, and more!